This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://commonfund.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI) on behalf of the NIH.
September 23, 2018
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
NIH Common Fund Extracellular RNA Communication program (https://commonfund.nih.gov/exrna) was established in 2012 to uncover fundamental principles of exRNA generation, secretion, and transport; identify and develop a catalog of exRNA found in normal human body fluids; and investigate the potential for using exRNAs in the clinic as therapeutic molecules and/or biomarkers of disease. The Common Fund supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for transformation of research processes.
ExRNAs can act as endocrine signaling molecules, both locally and systemically, representing a novel paradigm in intercellular communication. ExRNAs are transported in body fluids in association with an array of carrier vehicles of varying complexity including extracellular vesicles (EVs), ribonucleoproteins (RNPs), and lipoproteins (LPPs). While these carriers (EVs, RBPs, and LPPs) share the functional attribute of protecting exRNAs from degradation by ubiquitous extracellular RNAses, their respective contributions to biodistribution, uptake, and/or function of their respective exRNA cargo in target cells is less clear. In humans, exRNAs have been found in virtually all body fluids examined, including blood, saliva, urine, breast milk, cerebral spinal fluid (CSF), amniotic fluid, semen, ascites, and pleural effusions. Reports in the literature suggest that exRNAs can have both protective and pathogenic roles in a variety of human diseases, and concomitantly serve as biomarkers for disease states. Taken together, the above findings highlight the important role secreted exRNAs have in regulating human health and disease.
While significant strides have been made in the field of exRNA biology, specific technological challenges remain. For example, RNA concentrations in biofluids are significantly lower than in tissues, necessitating the development of improved methods for their isolation and analysis. Currently available separation approaches do not adequately discriminate exRNAs encapsulated in EVs from exRNAs associated with non-vesicular RNPs or LPPs, and the carriers that transport exRNAs can affect exRNA recovery when different isolation methods are used. Ultimately, this can lead to unintended biases in exRNA population profiling. Little is known about the normal physiology of exRNAs, the functional consequences of exRNA uptake, or deficiency of uptake, by recipient cells, and the level of variation existing at the subpopulation level in both normal and disease states. These technological impediments limit the utility and impact of current efforts to catalog exRNAs and assess their contribution(s) to human health and disease.
These technology challenges will be addressed in the second stage of the NIH Common Fund exRNA Communication Program – Advancing Extracellular RNA (exRNA) Communication Research. Three companion FOAs will focus on the development of tools, technologies, and resources to catalyze the field of exRNA communication research.
Development of these tools, technologies, and resources will complement Stage 1 products and fill remaining knowledge and technology gaps. A consortium-structured grant mechanism is being used to support this research initiative to facilitate the generation of community accepted standards. Meeting the goals of the Stage 2 Initiatives will have a transformative effect on the field of exRNA biology as this will enable a greater understanding of the fundamental role of exRNAs in intercellular signaling and the translational potential to diagnose and treat diseases.
Extracellular vesicles (EVs) are membrane-enclosed particles that are secreted from various cell types into the extracellular space. EVs are heterogeneous in size, origin, and molecular cargo (including proteins, RNA, DNAs, and lipids). Additional complexity exists due to the heterogeneous exRNAs (mRNA, miRNA, lncRNA, and other RNA species) within EVs. These exRNAs can be transported to distal sites and may play an important role in intercellular communication by regulating physiological and pathological processes. Current methods for isolating EVs from complex biofluids are limited by the inability to sort EVs by cell or tissue of origin, creating significant technological barriers to analytical comparison of datasets generated across studies. Currently, it is not clear which RNA species (if any) are packaged and transported by different EV sub-populations, if the exRNA carrying capacity of different EV populations differs, or whether the exRNA content of EVs differs under homeostatic or pathologic conditions. Further, current technologies do not permit single EV isolation and analysis thereby limiting our understanding of the normal variation (heterogeneity) of EVs produced even using reductionist (i.e., cell culture) models. The diagnostic or therapeutic functionality of exRNAs can only be truly realized once the range of EV subpopulations from a given cell source are fully described and characterized for complete analysis of molecular cargo. Determining the origin of EVs from various tissues or cell types is essential for understanding where their cargo exRNAs originate and their effect on their target cells. Furthermore, being able to isolate and analyze single EVs from human biofluids would provide a unique opportunity to understand the cell or tissue from which their respective exRNAs originate and, importantly, would add significant depth to our understanding of exRNA communication. Ideally, a protocol(s) for isolating single vesicles should be (1) rapid and reproducible, (2) yield highly enriched EV subpopulations from a single source cell or tissue with no cross-contamination, and (3) have the capacity to analyze and catalog exRNAs present in the single EVs from various cell and tissue types. None of the separation technologies currently employed for EVs (i.e., differential ultracentrifugation, density gradients, polymer-based precipitation, microfiltration and size-exclusion-based methods) meet all these performance standards. Further, the diagnostic or therapeutic functionality of EVs can only be truly realized once the range of EV subpopulations from a given cell source are fully described and isolated for complete analysis of their molecular cargo. A number of approaches have been developed to characterize EVs in the clinical setting, including sandwich ELISA-based microarray chip, immunomagnetic exosome RNA (iMER) analysis, miniaturized micro–nuclear magnetic resonance (µNMR) microfluidic chip system, Exochip, and label-free high-throughput nano-plasmonic exosome assay (nPLEX) using surface plasmon resonance (SPR). However, none of these current methodologies can address EV heterogeneity or clearly define cell of origin for exRNA cargo.
Thus, there is a critical need to develop and validate novel tools, technologies, and approaches to characterize and sort EV subpopulations based on “cell of origin” from complex biofluids for downstream analysis and cataloging of their respective exRNAs and associated molecular cargo, with the capacity to do so at scale.
This FOA uses the UG3/UH3 cooperative agreement award mechanism. The UG3 phase will focus on technology development and feasibility using specific human cultured cells or tissue types (primary derived biopsies), animal models, or human biofluids. Support will be provided for up to two years for the initial proof of concept studies. Following NIH administrative review, the UH3 Phase will support activities to optimize, refine, and scale up validated EV isolation technologies, and using human biofluids. Successful technologies, information on PD/PI generated reagents, and associated protocols will be shared with the broader community via the exRNA Portal (exRNA.org). This will be the primary deliverable of this collaborative Common Fund-sponsored program.
In order to be responsive to this FOA, applicants are expected to:
UG3/UH3 transitions and milestones:
All projects will be milestone-driven with clear go/no-go quantifiable criteria. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed UG3 and UH3 milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official and the applicant will negotiate and agree on a final set of approved UG3 milestones which will be specified in the Notice of Award. These milestones will be the basis for judging the successful completion of the work proposed in the UG3 stage and progress towards interim milestones in the UH3 stage. Only UG3 projects that meet their milestones will have an opportunity to move to the UH3 phase. UH3 milestones will be the basis for judging progress towards and completion of interim milestones in the UH3 stage.
Applicants are expected to carefully read Section IV 2 for detailed application instructions.
Program Formation and Governance
The awards funded under this FOA will be cooperative agreements (see Section VI. 2. Cooperative Agreement Terms and Conditions of Award). Close interactions among the awardees and NIH will be required to maintain this complex program. The exRNA Communication Consortium (ERCC) governance will rest with the ERCC Program Steering Committee in collaboration with NIH Program Officials, with advice from a group of External Program Consultants (EPC) providing critical scientific and managerial insights, and subject to oversight by the NIH ERCC Working Group. The NIH ERCC Working Group consists of NIH programmatic staff from multiple Institutes and Centers of the NIH and the NIH Office of the Director. This group will be primarily responsible for the stewardship of the ERCC program. The NIH ERCC Working Group is chaired by the Director of the National Center for Advancing Translational Science (NCATS) and Director for the Division of Cancer Biology, National Cancer Institute (NCI). It reports to the Directors of the Office of Strategic Coordination/Common Fund and the Division of Program Coordination, Planning, and Strategic Initiatives for final funding decisions.
By participating in the exRNA Communication Consortium, the awardees are expected to agree to:
The DMRR and designated NIH databases will be utilized for the banking and distribution of biological and clinical data. Project PD(s)/PI(s) will be expected to harmonize all data and resource generation with the Data Management and Resource Repository (DMRR). The DMRR is expected to curate and disseminate information regarding critical reagents, and resources and promote and facilitate cross-project collaborations (see RFA-RM-18-026).
Technical Assistance Webinar
All applicants are strongly encouraged to contact NIH staff to discuss the alignment of their proposed work with the goals of this FOA and the ERCC program. A technical assistance webinar will be held for potential applicants. NIH staff will be available to answer questions related to this and companion FOAs. Participation in the webinar is optional. No pre-registration is required, but participants are asked to submit questions ahead of time to firstname.lastname@example.org. The slides as well as some frequently asked questions will be available at https://commonfund.nih.gov/exrna following the webinar.
The webinar will be held on August 24, 2018 from 2-3:30 PM, EST.
Join us via WebEx using this link:
Event number: 629 822 206Event password: exRNA
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims:In the single Specific Aims attachment, provide the overall goals or hypotheses for the entire project period and identify separate Specific Aims to be accomplished in the UG3 phase and in the UH3 phase.
The UG3/UH3 phases must be submitted as a single application but the approach should be clearly organized into two stages: UG3 Development (phase 1) and UH3 Optimization (phase 2). All projects should be milestone-driven with clear go/no-go criteria that are quantifiable. Milestones and the timeline for each stage must be provided in a separate heading at the end of the Approach section for each UG3 and UH3 component and include the following:
Appropriate benchmarks for assessing milestones and project transitions will be negotiated between the NIH and applicant prior to funding decisions and will be specified in the Notice of Award.
The UG3 Development Phase:
UG3 projects will support feasibility and proof of principle studies for novel isolation technologies for EV subpopulations using physiologically relevant human 3D cell models, tissue types derived from primary biopsies, animal models, or human biofluids. Studies will focus on identifying and cataloging exRNA cargos in identified EV subpopulations in order to characterize “cell of origin” and intended target cell. Molecular tools as well as genetic or barcoding-based systems that allow assessment of separation performance (i.e., recovery, purity, functional output) of specific EV subpopulations are also encouraged. The emphasis of the UG3 phase is to develop separation technologies capable of rapidly separating EV subpopulations into relatively homogenous populations (based on biophysical characteristics) from a single sample. UG3 investigators will need to be flexible in the design and execution of their specific applications through collaboration with other UG3 groups in identifying the optimum protocol(s) for isolating EV subpopulations from various biofluids or tissue types, and to develop common best practices. Applicants should:
Transition to the UH3 Optimization Phase:
UG3 projects that have met the scientific milestones and other requirements (listed below) will be eligible for transition to the second UH3 Optimization Phase after NIH administrative review.
Go/No-Go Transition Milestone for transition from the UG3 Phase to the UH3 Phase:
Applicants must be supported by clearly identified Go/No-Go transition milestones for completion of the UG3 phase at the end of Year 2 and transition to the UH3 phase and timelines for assessing progress.
UH3 Optimization Phase:
The UH3 Optimization Phase should focus on optimizing, refinement, and scale up validated EV isolation technologies, towards the end goal of the analysis of single EVs isolated from complex human biofluids. Project in the UH3 phase must include the use of human biofluids. Resulting data should be compared to previously deposited exRNA Atlas datasets (http://exrna-atlas.org/) with the goal of determining the exRNA cell of origin and intended target cell. Activities supported in this phase include, but are not limited to:
The following modifications also apply:
Sharing within the ERCC
The ERC program aims to maximize the benefits of sharing, while protecting the intellectual property of the data generators. Prepublication sharing of data within the consortium will allow collaboration across initiatives and further the progress of the ERC Program towards its goals and objectives. Therefore, the ERC program requires that data, metadata, and resources generated from ERC funding be made available to other ERCC members immediately upon being considered “shareable”. When ERC-generated material under embargo is shared within the ERCC, it will be considered confidential with the understanding that the information will not be used or disclosed by ERCC members unless explicitly agreed upon by the originator of the data under mutually acceptable terms. That is, Consortium members may not publish using material generated by other consortium members without a collaboration or other agreement, or until the material in question has been made available to the public . As such, ERCC investigators accessing embargoed material only available to members of the ERCC must sign a non-disclosure form agreeing to these terms.Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The UG3/UH3 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. A UG3/UH3 grant application need not have substantial preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the UG3 and UH3 Phases.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA:
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA?:
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA:
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
NIH exRNA Communication Working Group (WG): Consists of NIH programmatic staff from multiple Institutes and Centers of the NIH. This group will be primarily responsible for the stewardship of the exRNA Communication Program.
Steering Committee (SC): The SC will provide coordination activities for the exRNA Communication Program. The SC will include PDs/PIs of each of the awards and NIH exRNA Communication WG members. The SC will be chaired by two PD/PIs that are nominated by the SC and approved by the NIH. The SC will establish subcommittees to oversee the development and implementation of consortium policies including data release. The number of NIH votes may not exceed one third of the total number of votes on the SC. The number of votes from a multiple PI award will be one. Votes will inform recommendations to the NIH.
External Scientific Consultants (ESC): The NIH exRNA Communication WG will recruit outside experts (4-6 senior scientists; non-awardees) of relevance to the exRNA Communication Program. The ESC will be responsible for reviewing and evaluating the progress of the exRNA Communications Consortium toward meeting their individual and collective goals. The ESC will be appointed by and provide recommendations to the NIH about continued support of the components of the Consortium. The membership of the ESC may be enlarged permanently, or on an ad hoc basis, as needed. The ESC will meet at least once a year. During part of this meeting, there will be a joint meeting with the Steering Committee to allow the ESC to interact directly with the awardees. Annually, the ESC will provide comments regarding progress of the Consortium and on any changes that may be necessary to the NIH.
ExRNA Communication Consortium (ERCC): The ERCC will be made up of exRNA Communication awardees, the NIH exRNA Communication WG and other scientists and groups the SC agrees to include within the Consortium. The Consortium structure is meant to enable the overall goals of the exRNA Communication Program.
The PD(s)/PI(s) will have the primary responsibility for:
The Program Director/Principal Investigator (PD/PI) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD/PI and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.
NIH Project Scientists:
Areas of Joint Responsibility include:
A SC will serve as the main governing board of the ERCC. The SC membership will include NIH Project Scientists and the PD/PI of each awarded cooperative agreement. The PD/PI of each award (or designee) will have one vote on the SC. The Project Scientists may vote, but the total votes will count as a maximum of one-third of the total number of votes. The SC Chairs will not be NIH staff members. Additional members may be added by action of the SC. Other government staff may attend the SC meetings, if their expertise is required for specific discussions. The SC will:
Dispute Resolution:Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Kevin Howcroft, Ph.D.
National Cancer Institute (NCI)
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